“The clinical study evaluation has demonstrated the Crux VCF System device can be used safely for the prevention of recurrent PE.”
Back in January we reported on the CE mark approval of Californian Vascular Company Crux Biomedical’s clever Vena Cava Filter(VCF) here. Now the company has issued a press release detailing successful clinical trial results, first reported in our previous post and now presented formally at last week’s Society of Interventional Radiology Meeting
Crux’s VCF trial, presented at the Society of Interventional Radiology Meeting, demonstrated a 98% deployment and retrieval success rate with no embolisations, migrations of fractures noted at 6 months follow-up.
Vena Cava filters are designed to trap blood clots that can lead to potentially fatal pulmonary embolisms (PE) among patients at risk. By obstructing the blood flow through the lungs, pulmonary embolisms (PE) cause difficulty breathing, chest pain and palpitations. Each year in the United States, approximately 600,000 patients develop PE and an estimated 200,000 deaths occur.
The primary means of prevention and therapy of PE is systemic administration of anticoagulant agents, but this is contraindicated in many patients. These patients require alternate treatments to reduce the ongoing PE risk, including vena cava filters — small devices that are inserted in the inferior vena cava, the main blood vessel returning blood from the lower part of the body to the heart, to prevent blood clots from reaching the lungs.
The Crux Biomedical VCF was designed to address the limitations of currently available VCFs, including perforation, migration and inability to retrieve. “Crux designed a device that is both more versatile and simple to use,” stated Tom Fogarty, M.D., noted cardiovascular surgeon and founder of Crux Biomedical.
The recently completed pivotal trial, known as the RETRIEVE Clinical Study, was a prospective, single-arm, multinational investigational study to assess the safety, performance, and efficacy of the Crux VCF System as both a retrievable and a permanent device. The trial included 125 patients at high risk for PE and was performed at 22 centers in the United States, Australia, New Zealand and Belgium.
In the study, the technical success rate of filter deployment was 98 percent. Filter retrieval success was also 98 percent. The average retrieval time was 7 minutes, with the femoral approach used for retrieval in 70% of cases. By the 6-month follow up of the study, no embolisations, migrations, or fractures were observed.
The presentation at the SIR 2012 Annual Scientific Meeting, titled “The Results of the Crux Vena Cava Filter RETRIEVE Trial” was authored by Robert R. Mendes, M.D., and was presented during the IVC Filters Scientific Session.
“The Crux device demonstrated an excellent safety profile,” stated Robert R. Mendes, M.D., Principal Investigator of the study; Associate Professor of Surgery, University of North Carolina; and Chief of Vascular Surgery, Rex UNC Healthcare. “The clinical study evaluation has demonstrated the Crux VCF System device can be used safely for the prevention of recurrent PE.”
As reported earlier, the Crux VCF has received CE Mark approval for commercial use in the European Union. The system is being studied in the United States under an approved Investigational Device Exemption (IDE) Study. FDA 510(k) clearance for commercial distribution in the U.S. is pending.
SOURCE: Crux Biomedical